Standards for Child Resitant Packaging (CRP)

The history of child resistant packaging begins in the United States in 1970. The “Poisons Prevention Packaging Act” (PPPA) provides that products which can be harmful to children must be packaged in a child resistant way. Numerous accidents involving household-, gardening- and automotive chemicals as well as accidents involving drugs and other hazardous substances initiated the process of legislation as these incidents often had traumatic consequences for both children and parents. It is certainly due to that fact that today, more and more products are sold in child resistant packaging.

Under the PPPA standardized testing procedures for child safe packaging were fixed in order to guarantee their functional reliability. During these tests, 200 children aged 42 to 51 months had to try and open a package. If 80% were not able to perform the task, the package could be considered child resistant. It was equally important, however, that adults, especially the elderly, were able to open and reseal the package as well.

Many other countries followed the American example and established similar standards which differed mainly in size and composition of the test groups, in length of the tests and sometimes in the analysis procedure.

Several legal requirements lay down the international use of child resistant packaging. Find the most important standards for child safe packaging in brief in the text below.


1. ISO 8317 (2003)

ISO 8317 (2003) - equivalent to DIN EN ISO 8317 (2004) - is the international standard for reclosable child resistant packaging. It applies to pharmaceutical as well as to chemical-technical products. As most child safe packagings fall into this category, ISO 8317 (2003) is the most important standard.

Part of this standard are two testing procedures for packagings. In one test with up to 200 infants aged 42 to 51 months, the children must not be able to open the packaging, which is filled with an innocuous substitute, while a group of people aged 50 to 70 must be able to open the packaging without difficulty. Only packagings that have been considered child resistant in tests with infants as well as convenient for elderly people according to the standards meet ISO 8317 (2003).

Tests with infants aged 42 to 51 months

The children have to try and open the package in five minutes’ time in whichever way they can think of. After five minutes, they are shown how to open the package once and without any further comment. Then the children try for another five minutes to open the package.

The packaging is to be regarded as child resistant if not more than 15 per cent of the children can manage to open the package within the first five minutes. Considering the whole testing period of ten minutes, not more than 20 per cent of the children must be able to open the packaging.

If only very few infants manage to open the package during the tests, the number of children may be reduced to fewer than 200.

Tests with senior citizens aged 50 to 70

During the senior citizens test, a group of 100 people aged 50 to 70 have to open a packaging within five minutes without any prior demonstration. In a second attempt they have to open it within one minute. The packaging is considered as suitable and convenient for senior citizens if at least 90 per cent of the group is able to open and reclose the packaging correctly.

The testing group of 100 people aged 50 to 70 is to be made up in the following way: 25 people aged 50 to 54, 25 people aged 55 to 59 and 50 participants aged 60 to 70. In every group, 70 per cent of the participants have to be women.

Important: Older certificates or test reports according to EN 28317 (1994) or ISO 8317 (1989) are not valid anymore and have to be adapted.


2. EN 862 (2005)

EN 862 (2005) - equivalent to DIN EN 862 (2006) - is the international standard for non-reclosable child resistant packagings for non-pharmaceutical products.

There are different types of non-reclosable child resistant packaging such as packagings the content of which is used up in one application (unit dose, one unit), refill packs, sealed up bags, flow packs and packagings that are made up of several joint single packages for single use (e.g. blister packs).

Non-reclosable means that the whole content is used all at once; the child safety mechanism can not be reconstructed.

Similar to the testing procedures of ISO 8317 (2003), infants aged 42 to 51 months try to open the packaging within 5 (or 10) minutes. The evaluation is done as in ISO 8317 (2003) mainly.

Tests involving senior citizens between 50 and 70 are optional.

Important: Older certificates or test reports according to EN 862 (2001) are not valid anymore and have to be adapted.


3. EN 14375 (2003)

EN 14375 (2003) - equivalent to DIN EN 14375 (2004) - is the European standard for non-reclosable child resistant packagings for pharmaceutical products. EN 14375 has replaced DIN 55559 which is not applicable anymore.

This standard is especially relevant for blister packs or for stick packs and granule bags.

As in ISO 8317 (2003), there are two necessary tests in which it must be proven that infants aged 42 to 51 months cannot open the packaging while people between 50 and 70 years can.

The testing procedures are mainly the same as with ISO 8317 (2003), that is two tests of five minutes for infants and one test of five and one test of one minute for adults. There is, however, one important difference: During the infant tests, a packaging is to be considered as “opened” according to the standard only when the infant could remove more than eight units from the package (e.g. blister pack).

Please note that during these tests, the child must have access to at least ten units of dosage. The conclusion that a stick pack or a blister containing less than eight units does not need to be packaged in a child resistant way is wrong and might lead to serious accidents.

It is highly dangerous to define package as “opened” if the testing person could remove more than eight units, because there are obviously many drugs that are very dangerous to infants even if they swallow far less than eight units by mistake. US requirements according to US 16 CFR § 1700.20 say that the definition of “opened” (that is the number of units removed) depends on the degree of dangerousness of the active ingredient (degree of toxicity). Compared to the US-standards, the success and reliability of EN 14375 (2003) must thus be put into question.

Important: Older certificates or test reports according to DIN 55559 are not valid anymore and have to be adapted.